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EP3787673A4 - METHOD FOR PREPARING STREPTOCOCCUS PNEUMONIAE POLYSACCHARIDE CARRIER PROTEIN CAPSULAR CONJUGATES - Google Patents

METHOD FOR PREPARING STREPTOCOCCUS PNEUMONIAE POLYSACCHARIDE CARRIER PROTEIN CAPSULAR CONJUGATES Download PDF

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Publication number
EP3787673A4
EP3787673A4 EP19795761.6A EP19795761A EP3787673A4 EP 3787673 A4 EP3787673 A4 EP 3787673A4 EP 19795761 A EP19795761 A EP 19795761A EP 3787673 A4 EP3787673 A4 EP 3787673A4
Authority
EP
European Patent Office
Prior art keywords
carrier protein
streptococcus pneumoniae
pneumoniae polysaccharide
polysaccharide carrier
conjugates
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP19795761.6A
Other languages
German (de)
French (fr)
Other versions
EP3787673A1 (en
Inventor
Patrick Leonard AHL
Akhilesh Bhambhani
Christoper Jon FARRELL
Patrick Mchugh
Morrisa C. JONES
Daniel D. ROTH
Jessica R. SINACOLA
Justin STANBRO
Matthew P. WATSON
Emily WEN
Michael A. WINTERS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck Sharp and Dohme LLC
Original Assignee
Merck Sharp and Dohme Ltd
Merck Sharp and Dohme LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Merck Sharp and Dohme Ltd, Merck Sharp and Dohme LLC filed Critical Merck Sharp and Dohme Ltd
Publication of EP3787673A1 publication Critical patent/EP3787673A1/en
Publication of EP3787673A4 publication Critical patent/EP3787673A4/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/09Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092Streptococcus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/61Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6037Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/64Medicinal preparations containing antigens or antibodies characterised by the architecture of the carrier-antigen complex, e.g. repetition of carrier-antigen units
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP19795761.6A 2018-04-30 2019-04-25 METHOD FOR PREPARING STREPTOCOCCUS PNEUMONIAE POLYSACCHARIDE CARRIER PROTEIN CAPSULAR CONJUGATES Pending EP3787673A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862664590P 2018-04-30 2018-04-30
PCT/US2019/029048 WO2019212846A1 (en) 2018-04-30 2019-04-25 Methods for producing streptococcus pneumoniae capsular polysaccharide carrier protein conjugates

Publications (2)

Publication Number Publication Date
EP3787673A1 EP3787673A1 (en) 2021-03-10
EP3787673A4 true EP3787673A4 (en) 2022-04-27

Family

ID=68386725

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19795761.6A Pending EP3787673A4 (en) 2018-04-30 2019-04-25 METHOD FOR PREPARING STREPTOCOCCUS PNEUMONIAE POLYSACCHARIDE CARRIER PROTEIN CAPSULAR CONJUGATES

Country Status (6)

Country Link
US (3) US20210252125A1 (en)
EP (1) EP3787673A4 (en)
JP (1) JP7506605B6 (en)
KR (1) KR20210005158A (en)
CN (2) CN120661645A (en)
WO (1) WO2019212846A1 (en)

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CN110225757A (en) * 2017-01-31 2019-09-10 默沙东公司 By the method for S. pneumoniae serotypes 19F production capsular polysaccharide protein conjugate
CA3050120A1 (en) 2017-02-24 2018-08-30 Merck Sharp & Dohme Corp. Enhancing immunogenicity of streptococcus pneumoniae polysaccharide-protein conjugates
US10729763B2 (en) 2017-06-10 2020-08-04 Inventprise, Llc Mixtures of polysaccharide-protein pegylated compounds
KR102736151B1 (en) 2017-09-07 2024-11-28 머크 샤프 앤드 돔 엘엘씨 Pneumococcal polysaccharide and its use in immunogenic polysaccharide-carrier protein conjugates
KR102734995B1 (en) 2017-09-07 2024-11-26 머크 샤프 앤드 돔 엘엘씨 Pneumococcal polysaccharide and its use in immunogenic polysaccharide-carrier protein conjugates
UA128603C2 (en) 2017-12-06 2024-08-28 Мерк Шарп Енд Доум Елелсі Compositions comprising streptococcus pneumoniae polysaccharide-protein conjugates and methods of use thereof
CN112074294B (en) 2018-04-30 2025-07-11 默沙东有限责任公司 Method for producing Streptococcus pneumoniae capsular polysaccharide carrier protein conjugate from freeze-dried pellets
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JP7397000B2 (en) 2018-04-30 2023-12-12 メルク・シャープ・アンド・ドーム・エルエルシー Method for providing a homogeneous solution of lyophilized mutant diphtheria toxin in dimethyl sulfoxide
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WO2021146681A1 (en) * 2020-01-17 2021-07-22 Inventprise, Llc Multivalent streptococcus vaccines
CN113930356B (en) * 2021-09-23 2022-08-05 艾美卫信生物药业(浙江)有限公司 Freeze-drying method for fermentation production of diphtheria toxin non-toxic CRM197 protein strain

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CN112074294B (en) 2018-04-30 2025-07-11 默沙东有限责任公司 Method for producing Streptococcus pneumoniae capsular polysaccharide carrier protein conjugate from freeze-dried pellets
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Title
See also references of WO2019212846A1 *

Also Published As

Publication number Publication date
CN112074293A (en) 2020-12-11
US20230077640A1 (en) 2023-03-16
US20210252125A1 (en) 2021-08-19
CN120661645A (en) 2025-09-19
JP7506605B6 (en) 2024-07-16
JP7506605B2 (en) 2024-06-26
JP2021522288A (en) 2021-08-30
US20240261384A1 (en) 2024-08-08
US11992521B2 (en) 2024-05-28
WO2019212846A1 (en) 2019-11-07
EP3787673A1 (en) 2021-03-10
US12419943B2 (en) 2025-09-23
CN112074293B (en) 2025-07-11
KR20210005158A (en) 2021-01-13

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